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Zelnorm's Return: US FDA Panel Hands Down Split Decision On Constipation Drug's Target Population

 
• By Michael Cipriano

Seven advisory committee members said the treatment for irritable bowel syndrome with constipation should be labeled for females at low cardiovascular risk; three panelists, including two cardiologists, supported a narrower indication limited to low CV risk patients who also suffer from severe symptoms.

FDA Advisory Committee Feature image

The US FDA may have its hands full deciding how to limit the use of US WorldMeds LLC's 5-HT4 receptor agonist Zelnorm (tegaserod maleate), a drug designed for the treatment for irritable bowel syndrome with constipation (IBS-C), after an advisory committee delivered a split vote over the most appropriate target population.

On Oct. 17, seven of 12 members of the Gastrointestinal Drugs Advisory Committee voted that they expect the benefits of Zelnorm to outweigh its risks in IBS-C females at low...

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